Note: This role is also known as GRA Global Regulatory Lead (GRA GRL)
To empower in providing leadership for the regulatory strategy of one or more in-line and pipeline assets across one or more therapeutic areas
To collaborate with leaders across the organization to serve as the ‘face of the asset’ from a regulatory perspective
To formulate, develop, and execute a comprehensive regulatory strategy integrating US and ex-US regulatory requirements
To ensure the conceptualization, development, and implementation of efficient global registration pathways to secure approvals, as well as maintain and potentially expand licenses in one or more geographies
To engage health authorities and drive product development, global registration, and ultimately achieve the desired labeling for one or more assets within or across therapeutic areas
To develop a team of US and/or global regulatory leaders, as assigned
To serve as a key member of the Global Regulatory Affairs Leadership Team (GRA LT), if assigned
Key Roles and Responsibilities
Provide strategic, tactical, and operational direction and guidance to product teams for assigned inline and/or pipeline assets in one or more therapeutic areas
Serve as key corporate regulatory contact and source of regulatory information and guidance for the US and other applicable markets
Serve as a line manager by constructing and developing a team (as resources are assigned)
Responsible for developing, executing, and maintaining the regulatory requirements for assigned programs, as well as managing regulatory commitments
Stay abreast of regulatory agency regulations, directives, guidelines, and policies that could impact product development, in order to assess approval pathways and identify potential issues
Identify and communicate all product development issues to management that could impact product submission, approval, or launch
Set and monitor submission timelines in coordination with other key stakeholders
Facilitate and lead all communications with Regulatory Agencies or Health Authorities, as applicable
Ensure communication with the regulatory body follows the established procedure within the department
At times, other functional areas may need to discuss matters with the Health Authority alongside their counterparts at the regulatory agency. The Regulatory Strategist/Lead should always serve as the point of contact and lead this interaction
Ensure that any communication documented according to established procedures is distributed within the Global Regulatory Affairs team and to any other external department directly affected by the communication
Must be involved in writing or facilitating the authoring of certain regulatory sections of product submissions.
Develops and manages relationships with external regulatory agencies, industry groups, and business partners.
As applicable, shall review audit reports, regulatory agency inspection reports, and responses to inspection observations, if any, when received.
Compiles, prepares, and reviews regulatory submissions to regulatory agencies, as applicable.
Conduct department-level training, as necessary, to educate regulatory strategists and other roles within the department on regulatory requirements, policies, and procedures.
Participate in the authoring and/or review of departmental procedures/guidance, as applicable.
Participate in in-licensing/due diligence review activities, as needed.
Qualification, Skill and Competencies Requirements
Advanced degree preferred (PhD, MD, PharmD, MBA)
Extensive global regulatory leadership as demonstrated by experience (> 15 years), milestones reached (e.g., original/supplemental approvals, expedited program designations), and health authority engagements (e.g., FDA, EMA, and others)
Strong staff and organizational development experience (e.g., building teams, and coaching and training both new and experienced staff); demonstrated strengths in delegation, resource allocation, and workload prioritization.
Broad experience in and across regulatory disciplines (notably global/regional strategy, labeling, clinical, nonclinical, CMC)
Direct experience and expertise in authoring and filing regulatory documentation across major regulated markets
Ability and interest in building and/or working a nimble resourcing environment
Job Duration
Full Time Part time
Job Location
Global
Reporting To
Senior General Manager, Head of Global Regulatory Affairs, India
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